Efficacy and Safety of Lambdalina (Lidocaine Cream) Versus Placebo as an Anesthetic for Laser Hair Removal

Inclusion criteria

• Women ≥ 18 and ≤ 65 years old.
• Laser hair removal treatment session in the legs in the area from the knee to the ankle (first or second application).
• Able of accomplishing the study's requirements.
• Negative result in the pregnancy test.
• Sterile or surgically sterilized women (hysterectomy, tubal ligation) or using adequate contraceptive methods.
• Written informed consent prior to inclusion in the trial.

Exclusion criteria

• General exclusion criteria:

• Pregnant or breastfeeding.

• Current or previous medical conditions:
• Skin type 5 or 6 or a history of photosensitivity.
• Cardiovascular diseases such as unstable angina, or severe heart failure (New York Heart Association III or IV).
• Neuropathy or paresthesia.
• History of hepatic failure.
• Autoimmune diseases.
• Allergies to peanuts and/or soy and/or any components of the formulation.
• Use or dependence on prohibited substances.
• Other contraindications specified in the summary of product characteristics.

• Current or previous concomitant medications:
• Any anesthetic or analgesic treatment during 2 hours prior of study entry.
• Concomitant treatment with antiarrhythmic drugs of class I (eg. tocainide, mexiletine) or class III (eg. amiodarone, sotalol), anticoagulants, anti-platelet aggregating and/or beta-blockers.
• Active wounds or irritations in the area to be treated.
• Topical treatment with corticosteroids or other topical agent in the area to be studied.